20130905 Technique Guidesynthes.vo.llnwd.net/o16/LLNWMB8/US Mobile/Synthes North...CA XXXXA 8/13 XX/XX Mitek Sports Medicine Limited Warranty and Disclaimer: DePuy Mitek, Inc. products

Mitek Sports MedicineLimited Warranty and Disclaimer: DePuy Mitek, Inc. products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed.

WARNING: In the USA, this product has labeling limitations. See package insert for complete information.

CAUTION: USA Law restricts these devices to sale by or on the order of a physician.

To order in the U.S. call, Johnson & Johnson Health Care Systems Inc. Customer Support Services at 800-255-2500.

Not all products are currently available in all markets.

Implants Instruments

RIGIDLOOP ordering information

Product # Description

232009 RIGIDLOOP 15mm Fixed Loop Implant










232034 RIGIDLOOP XL Button


232037 RIGIDLOOP ACL Disposables Kit (Sterile)

232025 RIGIDLOOP Beath Pin

232028 RIGIDLOOP 4.5 mm Cannulated Reamer

232030 RIGIDLOOP Standard Depth Gauge (Non-Sterile)

232031 RIGIDLOOP Variable Depth Gauge (Non-Sterile)

232032 RIGIDLOOP Instrument Caddy (Non-Sterile)

232033 RIGIDLOOP Silicon Mat for Instrument Caddy (Non-Sterile)

215451 Instrument tray lid (Non-Sterile)

Getting your patients back totheir passion is our passion.

RIGIDLOOP offers super strength and minimal elongation1

Ultimate strength of loop construct (N)

Elongation of loop construct (mm)

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15mm loops

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Reference. 1. Internal test data, ref. DHF-102035-MEMO14 &16.

DePuy Mitek, Inc.325 Paramount DriveRaynham, MA 02767-0350USA

Distributed in the USA by: DePuy Mitek, Inc.325 Paramount DriveRaynham, MA 02767USATel: +1 (800) 382-4682

Medos International SÀRL Chemin-Blanc 38 2400 Le Locle Switzerland

Authorized European Representative:DePuy International, Ltd.St Anthony’s RoadLeeds LS11 8DTEnglandTel: +44 (0) 113 387 7800Fax: +44 (0)113 387 7890

1-800-382-4682 | www.depuysynthes.com

©DePuy Synthese Mitek Sports Medicine, a division of DOI 2013. All rights reserved. CA XXXXA 8/13 XX/XX

































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15mm loops

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2017

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RIGIDLOOPTM

Cortical Fixation Systemsurgical technique guide

RIGIDLOOP is an easy-to-use cortical fixation system for soft tissue ACL reconstructions. It offers superior fixation strength while minimizes graft laxity with its titanium implant and non-absorbable continuous braided loop design. The implant is preloaded with a white UHMWPE (ultra high molecular weight polyethylene) leading utility suture and a green #5 Ethibond® trailing suture.

The following surgical technique guide is for a femoral soft tissue ACL reconstruction.

(Sterile)

































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©DePuy Synthese Mitek Sports Medicine, a division of DOI 2013. All rights reserved. CA XXXXA 8/13 XX/XXCA 12543B 8/13

Mitek Sports Medicine

































500

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15mm loops

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(Sterile)

































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2500

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©DePuy Synthese Mitek Sports Medicine, a division of DOI 2013. All rights reserved. CA XXXXA 8/13 XX/XXCA 12543B 8/13


ETHIBOND is a registered trademark of Ethicon, Inc.

Mitek Sports Medicine

4 / Insert ImplantPass the graft through the loop until the loop is at the mid-point of the graft. With a surgical marker, make a mark on the graft for the femoral socket drill depth.

Using a passing suture, pull the leading (white) and trailing (green) sutures through the tibial and femoral tunnels.

Use the white leading suture to pull the implant/graft through the femoral tunnel until the mark on the graft is visible at the aperture. Gently remove any slack from the green trailing suture as you pull.

5 / Deploy ImplantDeploy, or flip, the button onto the lateral femoral cortex by pulling on the green trailing sutures.

Toggle the green and white sutures and pull on the distal ends of the graft to confirm button has deployed.

Cycle the knee. Perform tibial fixation with an INTRAFIX® Tibial Fastener System. Remove leading and trailing sutures.

RIGIDLOOP XL Implant The titanium XL implant provides additional width to the standard RIGIDLOOP fixation implant for use with tunnel openings ranging from 6-10mm.• Remove the leading and trailing sutures on the Standard

Implant.• Pass the Standard Implant through the hole in the XL

Implant from the bottom.• Align the Standard Implant until it sits flush in the recess

of the XL Implant.• Re-insert the leading and trailing sutures through both

implants.

3 / Determine socket drilling depth and loop sizeSelect the reamer size that corresponds with the diameter of the graft. Drill the socket to a depth of 10mm greater than the length of the graft in tunnel to allow for deployment of the button.

For example:• Total femoral tunnel length (from STEP 2) = 35mm• Desired amount of graft in tunnel = 20mm• Determine implant size. 35mm of total tunnel length –

20mm of graft in tunnel = 15mm loop• Determine socket drilling depth. Add 10mm to graft in

tunnel to flip the button. (NOTE: a minimum of 6mm isneeded to flip the button, but for general ease of use weuse 10mm)

• 20mm + 10mm = 30mm socket drill depth

2 / Measure the total femoral tunnel lengthRemove the passing pin and 4.5mm reamer. Insert the Standard Depth Gauge through the femoral tunnel until the hook rests on the outer lateral femoral cortex. Read the total femoral depth on the gauge.

1 / Create the femoral tunnelUsing the 2.4mm passing pin, drill a hole through the lateral femoral condyle. Using the 4.5mm cannulated reamer, create a tunnel by drilling over the passing pin and breaking through the lateral femoral cortex.

3 / OptionalThe RIGIDLOOP Variable Depth Gauge (product code 232031) provides these key measurements without the need to do the calculations.• Drill the RIGIDLOOP 2.4mm passing pin (232025)

through the lateral femoral condyle until the laser markreaches the surface of the intercondylar notch.

• Make a small incision in the skin around the passing pin.• Pass the Variable Depth Gauge over the distal end of the

passing pin until the tip of the gauge reaches the lateralcortex of the femur.

• Remove the gauge from the passing pin, being carefulnot to adjust the placement of the inner metal tube.

• Rotate the gauge to view each measurement. First locate the total femoral tunnel value. Rotate the gauge tolocate the desired graft in tunnel value.The corresponding implant loop size is located to the right of the graft in tunnel value in the gauge body window. Rotate the gauge again to read the corresponding femoral socket drill depth value.

• Slide a reamer size that corresponds with the graft diameter over the passing pin and drill the femoralsocket to the indicated depth.

• Slide the 4.5mm reamer over the passing pin and drill through the lateral cortex to create a hole for the button to advance through.

20130905 Technique Guidesynthes.vo.llnwd.net/o16/LLNWMB8/US Mobile/Synthes North...CA XXXXA 8/13 XX/XX Mitek Sports Medicine Limited Warranty and Disclaimer: DePuy Mitek, Inc. products

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